Trial document




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  DRKS00013973

Trial Description

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Title

Influence of Contralateral Routing of Signals (CROS) on Hearing Abilities of Different Groups of Cochlear Implant Users

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Trial Acronym

ABIntl-17-14

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The use of a CROS-device in unilateral CI-recepients can lead in combination with a CI-device to a better speech understanding in noise in comparision to CI-usage alone.
Device Naída CI Q90 sound processor, Naída Link hearing aids and Naída Link CROS
Study Design: Within subject comparison
Regulatory Objective: Post-market study
Study Population: 40 adult CI users and 10 adult normal hearing listeners as reference group
Inclusion Criteria
• Unilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side
• Bimodal group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side and hearing aid contralaterally
• Bilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on both sides
• Minimum of 18 years of age
• Minimum of six months experience with their hearing devices
• 65% speech recognition for the OlSa in quiet at 65 dB SPL with CI only (1st side)
• German language proficiency
• Ability to provide subjective feedback on sound quality and speech understanding
Exclusion Criteria
• Difficulties additional to hearing impairment that would interfere with the study procedures.
Primary Study Objective
The primary objective of this study is to compare the speech intelligibility with one CI and the contralateral CROS device to the speech intelligibility with CI and unaided contralateral side in the presence of speech shaped noise.
Primary Study Measure Difference in the speech reception threshold (SRT) in the OlSa in presence of speech shaped noise between CI only and CI + CROS, measured in dB SNR.
Secondary Study Objective To compare speech intelligibility and localization abilities between CI only and CI + a second hearing instrument (CI, HA or CROS)
Secondary Study Measure
Difference in speech reception threshold in dB for speech intelligibility and localization error for localization abilities, measured in dB SNR and degree, respectively, between CI only and CI + a second hearing instrument (CI, HA or CROS)
Study Schedule
December 01, 2017 to November 30, 2018
Study Monitoring
Advanced Bionics GmbH, European Research Center
Statistical Analysis
Co-operation Universitätsklinikum Freiburg and Advanced Bionics

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013973
  •   2018/03/16
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  •   no
  •   Approved
  •   588/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Z96.2 -  Presence of otological and audiological implants
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Interventions/Observational Groups

  •   Bilateral Cochlea Implant User group (N=10)

    speech intelligibility in quiet and noise,
    localization abilities,
    audiograms, subjective feedback via questionnaires
  •   Unilateral Cochlea Implant user group (N = 10)
    speech intelligibility in quiet and noise,
    localization abilities,
    audiograms, subjective feedback via questionnaires
  •   Group of patients with cochlea implant on one side and conventional hearing aid on the other side (N=20)
    speech intelligibility in quiet and noise,
    localization abilities,
    audiograms, subjective feedback via questionnaires
  •   normal hearing group (N=10)

    speech intelligibility in quiet and noise,
    localization abilities,
    audiograms, subjective feedback via questionnaires
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

• Speech intellegibility with CI and contralateral CROS device versus CI and unaided contralateral side
• OLSa measurment in dB in noise
• unilateral CI recipients

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Secondary Outcome

•Comparison of different device configurations (CI only, CI + CROS, CI + HA, CI + CI) in terms of differences in speech intelligibility in quiet
•Comparison of different device configurations (CI only, CI + CROS, CI + HA, CI + CI) as well as different microphone options (omni, UltraZoom, StereoZoom) in terms of differences in speech intelligibility in stationary speech shaped noise
•Comparison of different device configurations (CI only, CI + CROS, CI + HA, CI + CI) in terms of differences in localization abilities.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/02/20
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

•Unilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side
•Bimodal group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side and hearing aid contralaterally
•Bilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on both sides
•Minimum of 18 years of age
•Minimum of six months experience with their hearing devices
•65% speech recognition for the OlSa in quiet at 65 dB SPL with CI only (1st side)
•German language proficiency
•Ability to provide subjective feedback on sound quality and speech understanding

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Exclusion Criteria

• Difficulties additional to hearing impairment that would interfere with the study procedures.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Advanced Bionics GmbHEuropean Research Center
    • Mr.  Dr  Volkmar  Hamacher 
    • Feodor-Lynen-Straße 35
    • 30625  Hannover
    • Germany
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    • Advanced Bionics AG
    • Ms.  Martina  Brendel 
    • Laubisrütistrasse 28
    • 8712  Stäfa
    • Switzerland
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    • Advanced Bionics AG
    • Ms.  Martina  Brendel 
    • Laubisrütistrasse 28
    • 8712  Stäfa
    • Switzerland
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Sources of Monetary or Material Support

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    • Advanced Bionics GmbHEuropean Research Center
    • Mr.  Dr  Volkmar  Hamacher 
    • Feodor-Lynen-Straße 35
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Studienprotokoll
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